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FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO ® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD
RARITAN, N.J., August 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study. With this approval, XARELTO® is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) events in p...
Source: Johnson and Johnson - August 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revascularization, a c...
Source: Johnson and Johnson - October 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

New XARELTO ® (rivaroxaban) Peripheral Artery Disease (PAD) Data from EXPLORER Clinical Research Program to be Unveiled at American Heart Association (AHA) Scientific Sessions 2020
RARITAN, N.J., November 9, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that 10 data presentations will be shared at the virtual American Heart Association (AHA) Scientific Sessions 2020 from November 13-17. Most notably, four new sub-analyses of XARELTO® (rivaroxaban) from the landmark VOYAGER PAD trial, part of the EXPLORER global cardiovascular research program, will be presented, including two live, featured science oral presentations. “We're pleased VOYAGER PAD was selected to be front and center once again at a major medical congress, as there's an urgent need for data in ...
Source: Johnson and Johnson - November 9, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Submits New Drug Application to U.S. FDA for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO® (rivaroxaban) in pediatric patients. The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with congenita...
Source: Johnson and Johnson - June 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

What Causes Facial Nerve Palsy?
Discussion Facial nerve palsy has been known for centuries, but in 1821 unilateral facial nerve paralysis was described by Sir Charles Bell. Bell’s palsy (BP) is a unilateral, acute facial paralysis that is clinically diagnosed after other etiologies have been excluded by appropriate history, physical examination and/or laboratory testing or imaging. Symptoms include abnormal movement of facial nerve. It can be associated with changes in facial sensation, hearing, taste or excessive tearing. The right and left sides are equally affected but bilateral BP is rare (0.3%). Paralysis can be complete or incomplete at prese...
Source: PediatricEducation.org - June 3, 2019 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news

What Causes Sudden Vision Loss?
Discussion Vision loss, whether chronic or acute, is distressing at any time for patients and families. Prompt evaluation and treatment are important as maintenance of any acuity and light or movement is considered paramount. Most vision loss is due to chronic problems and aging issues but the differential diagnosis is broad. For any age, but especially children, uncorrected refractive errors can cause problems in not only in childhood but throughout someone’s lifetime. Visual impairment for distance vision is considered mild if worse than 6/12 in meters = 20/40 in feet or 0.3 LogMAR and for moderate impairment is 6/...
Source: PediatricEducation.org - September 5, 2022 Category: Pediatrics Authors: Pediatric Education Tags: Uncategorized Source Type: news